Case Book Completion and Query Summary by Site

Subtotals and totals

This report shows how many case books are complete and how many have no outstanding queries.

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  • Subtotals—By Country.Numeric columns—Total for each country. % columns—Percent for each country.
    • Numeric columns—Total for each country.
    • % columns—Percent for each country.
  • Totals—Overall subject count totals.
    • Numeric columns—Total for all countries.
    • % columns—Percent for all countries.

Table 3-29 Column descriptions

Column Description
Country

Data type: String

Description: The country in which a site is located, as entered in the Oracle InForm Administration interface.

Data source: Replicated from the Oracle InForm transactional database to the Reporting and Analysis database.

Site Mnemonic

Data type: String

Description: An abbreviation that identifies a site, as entered in the Oracle InForm Administration interface.

Data source: Replicated from the Oracle InForm transactional database to the Reporting and Analysis database.

Enrolled Subject Count

Data type: Numeric

Description: The number of subjects with started CRBs who have enrolled at the site and have not dropped out.

How calculated: For each site, counts subjects with started CRBs who have been enrolled in the Oracle InForm application and have not dropped out of the study.

UUID: PF_SC_COMPLETECTL

Data source: Derived for the report; not stored in the Reporting and Analysis database.

Incomplete CRBs (% of Incomplete CRBs)

Data type: Numeric

Description: The number of started CRBs that are not complete.

How calculated: Counts Case Report Books that have been started and have at least one expected form without a status of Data Entry Completed.

This value displays as both a total and a percentage of all started CRBs for subjects that have not dropped out:

[% incomplete CRBs] = [incomplete CRBs] * 100 / [started CRBs]

Data source: Derived for the report; not stored in the Reporting and Analysis database.

Incomplete CRBs with Queries (% of Incomplete CRBs with Queries)

Data type: Numeric

Description: The number of started CRBs that are not complete and that have open queries.

How calculated: Counts Case Report Books that meet all of the following criteria:

  • Have been started.
  • Have at least one expected form without a status of Data Entry Completed.
  • Have at least one expected form with at least one open or answered query.

This value displays as both a total and a percentage of all started CRBs for subjects that have not dropped out:

[% incomplete CRBs with queries] = [incomplete CRBs with queries] * 100 / [started CRBs]

Data source: Derived for the report; not stored in the Reporting and Analysis database.

Incomplete CRBs without Queries (% of Incomplete CRBs without Queries)

Data type: Numeric

Description: The number of started CRBs that are not complete and that have no outstanding queries.

How calculated: Counts Case Report Books that meet all of the following criteria:

  • Have been started.
  • Have at least one expected form without a status of Data Entry Completed.
  • Do not have any expected forms with any open or answered queries.

This value displays as both a total and a percentage of all started CRBs for subjects that have not dropped out:

[incomplete CRBs without queries] = [incomplete CRBs] - [incomplete CRBs with queries]

[% incomplete CRBs without queries] = [incomplete CRBs without queries] * 100 / [started CRBs]

Data source: Derived for the report; not stored in the Reporting and Analysis database.

Completed CRBs (% of Completed CRBs)

Data type: Numeric

Description: The number of started CRBs that are complete.

How calculated: Counts Case Report Books that meet all of the following criteria:

  • Have been started.
  • Have all expected forms with a status of Data Entry Completed.

This value displays as both a total and a percentage of all started CRBs for subjects that have not dropped out:

[complete CRBs] = [CRB count] - [incomplete CRBs]

[% complete CRBs] = [complete CRBs] * 100 / [started CRBs]

Data source: Derived for the report; not stored in the Reporting and Analysis database.

Completed CRBs with Queries (% of Completed CRBs with Queries)

Data type: Numeric

Description: The number of started CRBs that are complete and that have open or answered queries.

How calculated: Counts Case Report Books that meet all of the following criteria:

  • Have been started.
  • Have all expected forms with a status of Data Entry Completed.
  • Have at least one expected form with at least one open or answered query.

This value displays as both a total and a percentage of all started CRBs for subjects that have not dropped out:

[completed CRBs with queries] = [total CRBs with queries] - [incomplete CRBs with queries]

[% complete CRBs with queries] = [complete CRBs with queries] * 100 / [started CRBs]

Data source: Derived for the report; not stored in the Reporting and Analysis database.

Completed CRBs without Queries

Data type: Numeric

Description: The number of started CRBs that are complete and that have no open or answered queries.

How calculated: Counts Case Report Books that meet all of the following criteria:

  • Have been started.
  • Have all expected forms with a status of Data Entry Completed.
  • Do not have any expected forms with any open or answered queries.

This value displays as both a total and a percentage of all started CRBs for subjects that have not dropped out:

[complete CRBs without queries] = [complete CRBs] - [complete CRBs with queries]

[% complete CRBs without queries] = [complete CRBs without queries] * 100 / [started CRBs]

Data source: Derived for the report; not stored in the Reporting and Analysis database.